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NEONATAL Total Galactose Screening Assay

by LaCAR MDx Technologies Belgium EUDAMED

Ref E-IZ-576 EMDN W01010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05430002471860 Basic UDI-DIDate21 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
E-IZ-576
Primary DI / UDI-DI
05430002471860
Basic UDI-DI
B-05430002471860
EMDN Code
W01010199 Enzymes - other
Device Class
Class IVD General
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000001212

Other devices from Lacar MDX Technologies

See all devices from Lacar MDX Technologies →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED f68bcedc-9800-4f9a-a4df-891f6bfd26af 61 fields · synced 24 Oct 2026